Generic Brands and Products

News about Generic Brands and Products, including commentary and archival articles published in The New York Times.

Chronology of Coverage

Jun. 19, 2015

Sandoz and Momenta Pharmaceuticals immediately initiate sales of generic drug Glatopa after federal appeals court again invalidates patent for brand-name multiple sclerosis drug Copaxone; decision is serious blow to Teva Pharmaceutical; generic will cost 18 percent less than Copaxone, but will still cost patients more than $63,000 per year. MORE

Jun. 17, 2015

Two generic versions of ADHD medication Concerta remain on market despite evidence that they are inferior; Food and Drug Administration reported that generics were less effective than Concerta and gave Mallinckrodt Pharmaceuticals and UCB six months to prove otherwise, deadline that has since lapsed with neither company announcing plans to withdraw the drugs. MORE

Jun. 8, 2015

Editorial applauds Federal Trade Commission and state officials like New York Atty Gen Eric Schneiderman for vigilant oversight of drug manufacturers using underhanded tactics; notes manufacturers of brand-name drugs were trying to ward off competition from less expensive generic drugs in order to continue high levels of profit on pharmaceuticals; holds consumers and insurers deserve full access to safe, effective and far less costly generic equivalents. MORE

May. 29, 2015

Pharmaceutical company Cephalon will pay $1.2 billion to settle antitrust charges with Federal Trade Commission, largest settlement ever secured by FTC; company was charged with blocking generic competitors from entering market as patents expired on its lucrative sleep drug Provigil. MORE

Apr. 21, 2015

Teva Pharmaceutical Industries announces settlement of $512 million over claims by drug wholesalers and other companies that subsidiary Cephalon paid generic manufacturers to keep their cheaper versions of drug off market; settlement, largest ever paid to direct purchasers of drugs, must be approved by judge. MORE

Apr. 17, 2015

Food and Drug Admin approves first generic substitute for multiple sclerosis drug Copaxone, the biggest-selling product for Teva Pharmaceutical Industries; generic, developed by Sandoz and Momenta Pharmaceuticals, could introduce competition for drug that costs some $60,000 per year. MORE

Mar. 28, 2015

Generic drug makers challenge Food and Drug Admin's plan that would require them to take initiative to update their labels whenever health risks are discovered, shift that would expose them to legal liability. MORE

Jan. 31, 2015

Op-Ed article by Joseph E Stiglitz, Nobel laureate in economics, warns that influence of pharmaceutical companies on Trans-Pacific Partnership trade negotiations may result in higher drug prices worldwide and less innovation; notes that companies are seeking to keep or expand their monopolies on brand-name drugs by restricting competition from generics and undermining government regulation of drug prices. MORE

Jan. 8, 2015

Food and Drug Administration panel recommends approval of EP2006, more affordable version of cancer therapy drug Neupogen, also called filgrastim; if FDA acts on recommendation it will create era of competition for so-called biologic drugs, which are made out of living cells rather than synthesized from chemicals. MORE

Nov. 25, 2014

State and federal lawmakers are searching for ways to help patients struggling to pay high cost of drugs; prices of common generic medicines have jumped 500 percent or more in past 18 months, and continue to soar. MORE

Oct. 8, 2014

Lawmakers are investigating why the prices of some generic drugs have soared more than 1,000 percent in last year; demand that generic drug makers explain reasons for increases or potentially face new regulation. MORE

Sep. 16, 2014

Gilead Sciences, maker of one of costliest drugs in world, says it has struck deals with seven generic drug makers in India to sell lower-cost versions of Sovaldi, its hepatitis C medicine--a $1,000-a-pill treatment--in poorer countries; drug is on pace to exceed $10 billion in sales in 2014. MORE

Sep. 16, 2014

New York Attorney Gen Eric T Schneiderman files antitrust lawsuit seeking to stop pharmaceutical company Actavis from forcing patients with Alzheimer's disease to switch to new version of its widely used drug Namenda; argues move is attempt to blunt competition from low-priced generic versions. MORE

Jul. 9, 2014

Costs of some generic drugs, far cheaper to bring to market than brand-name pharmaceuticals, are nonetheless rising despite plentiful supply and ease of manufacture; Federal Trade Commission has been examining anticompetitive practices in generic drug industry but there is little that can be done if monopoly happens naturally as competing companies leave the market. MORE

Jun. 24, 2014

Recalls by two large Indian manufacturers, Wockhardt and Dr Reddy’s Laboratories, are latest in string of recent problems involving widely used generic heart drugs, especially those made in India; recalls come as Food and Drug Administration is taking closer look at quality of generic drugs, which account for more than 80 percent of prescriptions in United States. MORE

May. 31, 2014

Food and Drug Administration approves first generic version of Pfizer's anti-inflammatory painkiller Celebrex; drug, known generically as celecoxib, treats pain, rheumatoid arthritis, osteoarthritis and other conditions. MORE

Apr. 1, 2014

Supreme Court agrees to hear Teva Pharmaceutical Industries' appeal of lower-court ruling that invalidated a patent that would have protected its popular and lucrative multiple sclerosis drug, Copaxone, until September 2015; court’s decision could delay competitors’ generic versions of the drug. MORE

Mar. 27, 2014

Editorial urges approval of legislation that would authorize makers of generic drugs to update safety labels independently, without need for Food and Drug Administration approval; says current legislation, under which generic labels match those of name brand drugs, prevents patients harmed by generics from suing maker; holds change is needed to improve safety. MORE

Nov. 15, 2013

New guidelines governing use of cholesterol-lowering medicines represent huge change for doctors and a vast number of patients, but impact on drug industry is expected to be less tumultuous, largely due to relatively unprofitable status of generic statin drugs; changes do cast into doubt future of new class of cholesterol-lowering drugs known as PCSK9 inhibitors, which had been highly anticipated on Wall Street. MORE

Nov. 9, 2013

Food and Drug Administration proposes rule that would permit generic drug makers to update their labels if they received information about potential safety problems; move, if approved, would make generic firms equal to brand-name drug makers and open both to lawsuits by patients. MORE

Oct. 14, 2013

California Gov Jerry Brown vetoes bill that would have allowed biosimilar versions of biologic drugs to be substituted by pharmacists if Food and Drug Administration deemed them 'interchangeable' with the brand-name reference product. MORE

Oct. 6, 2013

News analysis; studies have found that many American consumers are skeptical of generic drugs and prefer their brand-name counterparts, despite knowing that they are for all intents and purposes identical. MORE

Oct. 2, 2013

Grocery store brands are challenging traditional brands from food companies and preserving or improving their own slim profit margins; Nielsen reports sales of store brands over last three years grew 18.2 percent, accounting for $111 billion in sales, compared with 7.9 percent for national brands with $529 billion. MORE

Sep. 17, 2013

Food and Drug Administration, citing concerns about drug quality, announces ban on imports of any products made at generic drug maker Ranbaxy’s new plant in Mohali, India. MORE

Sep. 3, 2013

Op-Ed article by industry experts Margaret Clapp, Michael A Rie and Phillip L Zweig warns a critical shortage of lifesaving generic drugs has persisted unabated one year after Pres Obama signed law meant to end it; calls on Obama administration and lawmakers to end protections for purchasing organizations that have colluded to suppress free-market competition in generic market. MORE

Jul. 4, 2013

Food and Drug Administration signals its intention to permit generic drug makers to make changes to their safety labels; move could open the door to lawsuits against generic drug companies for the first time since Supreme Court decision barred such suits in 2011. MORE

Jun. 29, 2013

Editorial criticizes Supreme Court decision that leaves little legal recourse for consumers who are harmed by generic drugs; calls on Food and Drug Administration to write new protective regulations holding generic companies liable for any harm their products cause. MORE

Jun. 25, 2013

Supreme Court rules, in 5-to-4 decision, that generic drug manufacturers could not be sued by patients who claim drugs they took were defectively designed; decision is significant victory for generic drug industry, but further narrows recourse for people who are injured by such drugs. MORE

Jun. 20, 2013

European Commission fines Danish pharmaceutical firm Lundbeck and number of generic producers total of 146 million euros ($195 million), for what it says are companies' attempts to block cheaper generic version of popular antidepressant citalopram. MORE

Jun. 19, 2013

Editorial welcomes Supreme Court ruling that allows Federal Trade Commission to bring antitrust charges against drug companies that pay competitors to delay putting cheaper generic drugs on market; contends, however, that while ruling is step in right direction, it does not go far enough. MORE

Jun. 18, 2013

Supreme Court rules in 5-to-3 vote that pharmaceutical companies can face antitrust charges by Federal Trade Commission for paying generic competitors to keep cheaper copies of a drug off the market; decision is likely to increase number of generic drugs in marketplace and benefit consumers. MORE

May. 14, 2013

Generic drug maker Ranbaxy pleads guilty to federal drug safety violations and will pay $500 million in fines to resolve claims that it sold subpar drugs and made false statements to the Food and Drug Administration about its manufacturing practices at two factories in India; settlement is largest in history involving generic manufacturer and drug safety. MORE

Apr. 20, 2013

Editorial notes regulatory action by Food and Drug Administration has prevented generic version of painkiller OxyContin from being marketed; expresses hope that generic companies can find way to market abuse-deterrent formulations of drug, which would help keep prices down and prevent abuse by public. MORE

Apr. 20, 2013

British antitrust authorities accuse pharmaceutical giant GlaxoSmithKline of paying three rivals to delay introduction of generic version of antidepressant drug Seroxat; charges are latest in series of so-called pay-for-delay cases drawing scrutiny from international regulators. MORE

Apr. 17, 2013

Food and Drug Administration says that it will not approve generic versions of the powerful narcotic OxyContin, painkiller that symbolized a decade-long epidemic of prescription abuse; decision is victory for those saying generic versions would feed street demand, but will also likely result in higher prices. MORE

Apr. 16, 2013

Big pharmaceutical companies are using safety law to prevent generic manufacturers from developing low-cost copies of their drugs; generic drug makers need samples of branded drugs to test their products and get them approved; increasingly, brand-name makers are refusing to sell them samples, saying they are protecting themselves in case drugs are somehow used improperly. MORE

Apr. 5, 2013

Editorial welcomes India's Supreme Court's ruling that pharmaceutical company Novartis should not be given patent for cancer drug because it was too similar to Novartis's earlier version; contends decision should help protect availability of cheap generic drugs for poor patients. MORE

Apr. 2, 2013

Indian Supreme Court rules that Indian makers of low-cost generic drugs can continue making copycat versions for diseases like HIV and cancer; debate over global drug pricing is highly contentious issue between developed countries and developing world, and ruling challenges pharmaceutical industry at a time when it is increasingly looking to emerging markets to counter lackluster sales in United States and Europe. MORE

Mar. 26, 2013

Several Supreme Court justices express skepticism about legality of payments by brand-name drug companies to potential generic competitors in exchange for keeping their cheaper, rival drugs off the market; questions and arguments come in case involving Actavis Group, Solvay Pharmaceuticals and Federal Trade Commission. MORE

Mar. 25, 2013

Generic and brand-name drug companies find themselves unlikely bedfellows as Supreme Court hears arguments on whether antitrust law is violated when pharmaceutical companies pay generics to keep their products off market; court's decision could have sweeping effect on one of largest segments of nation's economy. MORE

Mar. 11, 2013

Editorial cites upcoming Supreme Court case of Karen Bartlett, woman who was severely injured by a generic drug in 2004 and is still struggling to hold manufacturer liable; warns if court decides to limit ability of consumers to sue generic manufacturers, then Congress ought to amend laws to ensure that this plaintiff, and others hurt by these drugs, are compensated. MORE

Mar. 5, 2013

Supreme Court is set to hear arguments on whether Mutual Pharmaceutical Co can be held responsible for injuries to Karen Bartlett of Plaistow, NH, who was rendered legally blind after taking a mild generic painkiller; case is being closely watched by drug firms; outcome is likely to further clarify legal recourse for patients who take generic drugs. MORE

Feb. 9, 2013

Editorial cites case of biotechnology companies Amgen and Genentech, who are both lobbying state legislatures to limit competition to their biological drugs that will be losing patent protection; cautions state lawmakers not to limit access to generic versions of their drugs until Federal Drug and Administration issues final safety guidelines. MORE

Feb. 1, 2013

Jan. 29, 2013

Some of nation’s biggest biotechnology companies are lobbying in statehouses nationwide to limit generic competition to their blockbuster drugs; drugmakers Amgen and Genentech are proposing bills that would restrict ability of pharmacists to substitute generic versions for brand name products; say such measures are needed to protect patient safety. MORE

Jan. 12, 2013

Alabama Supreme Court rules that patient can sue brand-name pharmaceutical company for failing to warn about drug's risks even though patient took generic version; decision is likely to be closely read by lawyers with similar cases pending around the country. MORE

Jan. 2, 2013

Purdue Pharma and Endo Pharmaceuticals, makers of brand name pain-relief drugs OxyContin and Opana, introduce versions that are more resistant to tampering techniques abusers use to release the pills' narcotics; companies hope that move will convince regulators to delay generic versions of the drugs that are not tamper-resistant, arguing that older designs will feed street demand for strong painkillers. MORE

Dec. 8, 2012

Supreme Court says it will take a case involving a decade-long battle over whether a pharmaceutical company should be allowed to pay a competitor to keep a generic copy of a best-selling drug off the market; federal regulators say such deals violate antitrust laws while the pharmaceutical industry contends that they are just settlements of disputes over patents that protect the billions of dollars they pour into research and development. MORE

Dec. 7, 2012

Generic drug maker Mylan sues the Food and Drug Administration in an attempt to upend rival Ranbaxy's exclusive rights to produce generic form of blood pressure drug Diovan; FDA has still not given final clearance to Ranbaxy, months after the patent for the top-selling drug expired. MORE

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